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NCT05197361 Clinical Trial

Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion

Chronic Total Occlusion of Coronary Artery Clinical Trial

— FLOW-CTO  

Official title:
Evolución de Las Resistencias Microvasculares y Del Flujo Coronario Absoluto en Pacientes Con intervención Coronaria percutánea de Una oclusión crónica

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05197361
Other study ID # FLOW1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date September 30, 2022

Study information
Verified date March 2022
Source Parc de Salut Mar
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is an observational study which objective is to analyze, through a series of invasive parameters, the state of the coronary microvasculature immediately after the successful percutaneous coronary intervention of a chronic total occlusion and at 6 months after the index procedure. The aim of the study is to check the variation in the values of the index of microcirculatory resistance (IMR) and invasive absolute coronary flow (AF). The working hypothesis is that, in the follow-up of these patients, AF will increase significantly with respect to its baseline and, conversely, IMR will be reduced during the follow-up.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 34
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Those patients with a clinical indication for percutaneous coronary intervention of a chronic total occlusion. As a routine clinical practice in our center, it is proposed to perform a angiographic follow-up 6 months after the index procedure. Exclusion Criteria: - No specific exclusion criteria.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Invasive coronary physiology
Estimation of guide-wire coronary physiology parameters

Locations
Country Name City State
Spain Hospital del Mar Barcelona
Spain Hospital Universitari de Bellvitge Barcelona
Spain Hospital Puerta del Mar Cadiz
Spain Hospital Universitario de La Princesa Madrid

Sponsors (1)
Lead Sponsor Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variation in the values of IMR between basal and 6-months follow-up 6 months
Primary Variation in the values of absolute coronary flow between basal and 6-months follow-up 6 months
See also
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Completed NCT02477579 - A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions N/A
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